Medtronic seeks approval for cryoablation system for paroxysmal a-fib

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Medtronic has completed its pre-market approval (PMA) submission in consideration for FDA approval for its Arctic Front Cardiac CryoAblation catheter system, which is designed for patients with paroxysmal atrial fibrillation.

The PMA submission includes data from the STOP-AF (Sustained Treatment of Paroxysmal Atrial Fibrillation) clinical trial recently presented March 15 at the 59th annual scientific session of the American College of Cardiology. The clinical trial evaluated the safety and effectiveness of the Arctic Front Cryocatheter System compared to anti-arrhythmic drug therapy.

Currently, the Arctic Front Cardiac CryoAblation catheter system is not available for sale in the U.S., and is limited by federal law to investigational use only.